In recent years,the real-world studies(RWS)have attracted extensive attention,and the realworld evidence(RwE)has been acceptedto support the drug development in Chinaand abroad.However,there is stll a lack of standard...In recent years,the real-world studies(RWS)have attracted extensive attention,and the realworld evidence(RwE)has been acceptedto support the drug development in Chinaand abroad.However,there is stll a lack of standards for the evaluation of the quality of RWE.It is necessary to formulate a quality evaluation and reporting specification for RWE especially in traditional Chinese medicine(TCM).To this end,under the guidance of China Association of Chinese Medicine,the Quality Evaluation and Reporting Specification for Real-World Evidence of Traditional Chinese Medicine(QUERST)Group,including 24 experts(clinical epidemiologists,clinicians,pharmacologists,ethical reviewerand statisticians),was established to develop the specification.This specification contains the listing of classification of RWS design and RWE,the general principles and methods of RWE quality evaluation(26 tools or scales),25 types of bias in RWS,the special considerations in evaluating the quality of RWE of TCM,and the 19 reporting standards of RWE.This specification aims to propose the quality evaluation principles and key points of RWE,and provide guidance for the proper use of RWE in the development of TCM new drugs.展开更多
基金the National Natural Science Foundation of China(No.82074282)NMPA Key Laboratory for Clinical Research and Evaluation of Traditional Chinese Medicine。
文摘In recent years,the real-world studies(RWS)have attracted extensive attention,and the realworld evidence(RwE)has been acceptedto support the drug development in Chinaand abroad.However,there is stll a lack of standards for the evaluation of the quality of RWE.It is necessary to formulate a quality evaluation and reporting specification for RWE especially in traditional Chinese medicine(TCM).To this end,under the guidance of China Association of Chinese Medicine,the Quality Evaluation and Reporting Specification for Real-World Evidence of Traditional Chinese Medicine(QUERST)Group,including 24 experts(clinical epidemiologists,clinicians,pharmacologists,ethical reviewerand statisticians),was established to develop the specification.This specification contains the listing of classification of RWS design and RWE,the general principles and methods of RWE quality evaluation(26 tools or scales),25 types of bias in RWS,the special considerations in evaluating the quality of RWE of TCM,and the 19 reporting standards of RWE.This specification aims to propose the quality evaluation principles and key points of RWE,and provide guidance for the proper use of RWE in the development of TCM new drugs.
